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恒瑞医药(600276.SH):海曲泊帕乙醇胺片获准开展联合环孢素(CsA)用于初治非重型再生障碍性贫血(NSAA)的临床试验

Hengrui Pharmaceutical (600276.SH): Acitripopa ethanolamine tablets were approved to conduct clinical trials in combination with cyclosporine (CsA) for the initial treatment of non-severe aplastic anemia (NSAA)

Gelonghui Finance ·  Mar 23, 2023 15:45

Gelonghui March 23 丨Hengrui Pharmaceutical (600276.SH) announced that recently, the company received approval from the China Drug Administration (“China Drug Administration”) to issue the “Drug Clinical Trial Approval Notice” for acripoppa ethanolamine tablets, and will conduct clinical trials in the near future.

Approval conclusion: According to the “Drug Administration Law of the People's Republic of China” and related regulations, after review, after review, the hytrapopatanolamine tablets (specification 2.5 mg) received on December 28, 2022 met the relevant requirements for drug registration, and it was agreed to conduct clinical trials of combined cyclosporine (CsA) for the initial treatment of non-severe aplastic anemia (NSAA).

Hytrapopa ethanolamine tablets have been approved for marketing for two indications, namely: they were approved by the National Drug Administration in June 2021 for the treatment of adult patients with chronic primary immune thrombocytopenia who have not responded well to treatments such as glucocorticoids and immunoglobulins, and for the treatment of adult patients with severe aplastic anemia with poor efficacy of immunosuppressive treatment.

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